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NCT06800482Recruiting

A Study of Online Follow-up in Patients With Papillary Thyroid Cancer

A Randomized Controlled Study of Online Outpatient Follow-up in Patients With Papillary Thyroid Cancer After Surgery

Source: ClinicalTrials.gov · Last updated 30 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The randomized, actively controlled, non-inferiority trial is scheduled to begin in August 2024 and run through August 2026. Inclusion criteria: (1) has undergone microwave ablation of thyroid or thyroidectomy (including endoscopy and opening) at the Department of Thyroid Surgery of West China Hospital of Sichuan University, (2) is between 18 and 90 years old, (3) speaks Chinese, (4) has the email address and operational ability required to complete the visit, (5) does not have a mental illness or take psychotropic drugs, (6) Voluntarily participate in clinical trials and sign informed consent. Exclusion criteria: (1) postoperative hospital stay more than 3 days; (2) Inability to complete an online visit (no access to the device or the Internet); (3) High risk of postoperative complications (recurrent laryngeal nerve injury, etc.); (4) Inability to participate due to a medical condition, laboratory test results, or physical disability (as determined by the principal investigator or surgeon). The online outpatient follow-up was completed by thyroid surgeons of West China Hospital. Informed consent signed with a voluntary participant after a research team member contacts the patient and introduces the patient to the study. The investigators who contacted, enrolled, and randomly assigned patients included the principal investigator, the study coordinator, and the research assistant who had been specially trained in the study. According to the agreement, the participants randomly assigned to online visits will cross over with offline visits and withdraw from the clinical trial if :(1) unresolved technical issues, (2) inability to perform a full evaluation, (3) need/request prescription painkillers, and (4) additional care recommended by a physician. Other cross-cutting reasons include patient requests and scheduling conflicts. The information department of WestChina hospital obtained online and offline participants' demographic data and comorbidities, related information of chief complaint (including time of illness, information of last visit, drugs being used, contents of consultation, disease symptoms, conclusions of consultation, etc.), and online and offline outpatient information (including application time, reception time, patient satisfaction, etc.). Whether to prescribe medicine, whether to prescribe examination/admission certificate, outpatient cost, number of questions, number of return visits, etc.) Employment, living conditions and the highest education level were obtained through the questionnaire survey at the time of enrollment, and the information about participant experience and satisfaction was obtained through the questionnaire survey after follow-up. The investigators recorded the diagnosis and treatment details of the patients at three online/offline follow-up visits at 1, 3, and 6 months after surgery. The investigators reviewed the electronic medical record 30 days after the last follow-up to monitor for adverse events. Participants were surveyed by email 30 days after the last follow-up to assess adverse events, including readmissions. If the survey is not answered within a week, an electronic reminder is sent and two attempts are made to contact the participants by phone.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
388 (estimated)
First submitted
28 Nov 2024
Start date
7 Aug 2024
Primary completion date
7 Aug 2026
Lead sponsor
West China Hospital
NCT number
NCT06800482

What you commit to

  • Study type: Interventional
  • Planned participants: 388
  • From 7 Aug 2024 to the primary completion date, 7 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • has mental illness or take psychotropic drugs, and were not able to perform the surgery

Lab values

  • unable to participate due to comorbidities, laboratory test results or physical disability

Other

  • postoperative hospital stay more than 5 days
  • inability to complete an online visit (no access to the device or the Internet
  • high risk of postoperative complications (recurrent laryngeal nerve injury, etc.)
  • pregnancy

Who the study is looking for

  • clinical diagnosis of papillary thyroid cancer
  • has underwent thyroid surgery (including endoscopic and open thyroid surgery)
  • 18 to 90 years of age
  • spoke Chinese
  • has the ability to use mobile phones and the Internet to complete the visit
  • voluntarily participate in clinical trials and sign informed consent.

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
West China Hospital
Coordinator of this site? Confirm its status
ChengduChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.